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An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee at an institution that applies research ethics by reviewing the methods proposed for research involving human subjects, to ensure that the projects are ethical.
One big problem is the requirement for ethical approval by the institutional review board (IRB) for each research analysis meant for publication. [22] Some research resources do not require IRB approval. For example, CDWs with data of deceased patients have been de-identified and IRB approval is not required for their usage.
The department or agency in charge also has the power to suspend the research. During the course of the study, the IRB must document all meetings and activities. The guidelines that a research study must follow before being approved involves informed consent of the subjects, minimal risk to the subjects, and no abuse of "vulnerable subjects". [19]
A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.
Exenatide (also Exendin-4, marketed as Byetta) is the first GLP-1 agonist approved for the treatment of type 2 diabetes. Exenatide is not an analogue of GLP but rather a GLP agonist. [32] [33] Exenatide has only 53% homology with GLP, which increases its resistance to degradation by DPP-4 and extends its half-life. [34]
Insulin glargine/lixisenatide is approved as a prescription for adults with type 2 diabetes mellitus poorly controlled by lixisenatide or basal insulin alone. [6] According to the American Diabetes Association, combination treatment of a GLP-1 receptor agonist with basal insulin should occur after HbA1C levels remain above target (7% for most type 2 people with diabetes) following use of basal ...
An IB is intended to provide the investigator with insights necessary for management of study conduct and study subjects throughout a clinical trial. An IB may introduce key aspects and safety measures of a clinical trial protocol, such as: Dose (of the study drug) Frequency of dosing interval; Methods of administration; Safety monitoring ...
The main goal of diabetes management is to keep blood glucose (BG) levels as normal as possible. [1] If diabetes is not well controlled, further challenges to health may occur. [1] People with diabetes can measure blood sugar by various methods, such as with a BG meter or a continuous glucose monitor, which monitors over several days. [2]